510(k) K133047 ยท LAF Gas Chromatography, Methamphetamine
RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
| Applicant | Biophor Diagnostics, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Dec 18, 2014 |
| Received | Sep 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133047
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.